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Form 483

Koros USA, Inc. Form 483, 2014-02-14

FDA issued a Form 483 to Koros USA, Inc. on 2014-02-14 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Koros USA, Inc. · Moorpark, United States · Issued February 14, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

14 Feb 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kelvin Cheung

14 Feb 2014
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Kelvin Cheung

14 Feb 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kelvin Cheung

Inspected site

KUKoros USA, Inc.Moorpark, United States

Inspection team

KCKelvin Cheung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere